BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1871022 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17024
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE AND A RIGHT VENTRICULAR (RV) LEAD WERE ASSOCIATED WITH A REMOTE MONITORING ALERT FOR A LOW OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT DURING THE DEVICE'S DAILY MEASUREMENTS CHECK. THE PATIENT'S HEALTH CARE PROVIDER (HCP) AND BOSTON SCIENTIFIC FIELD REPRESENTATIVE WERE NOTIFIED OF THE ALERT. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THE DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED A SUBSEQUENT CHECK SHOWED THE OUT-OF-RANGE MEASUREMENT WAS A ONE-TIME OCCURRENCE, AND ALL OTHER MEASUREMENTS WERE NORMAL. THE PATIENT IS BEING FOLLOWED WITH A REGULAR SCHEDULE OF REMOTE-MONITORING AND OFFICE DEVICE CHECKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR N119| 4046| 0185| 4087